STATUS REGARDING DUPIXENT® LITIGATIONS

Biologics Litigation

We previously reported that Sanofi and Regeneron filed a declaratory judgment action seeking a ruling that its approved Dupixent® (dupilumab) product does not infringe Amgen’s U.S. Pat. 8,679,487 (“the ’487 patent”), and that Immunex, a wholly owned subsidiary of Amgen, later filed a complaint against Sanofi and Regeneron alleging that Dupixent® infringes the ’487 patent. On May 1, 2017, Sanofi and Regeneron voluntarily dismissed their declaratory judgment action. On May 26, 2017, Defendants, Sanofi and Regeneron, filed a motion to dismiss Immunex’s complaint for failure to state a cause of action. Immunex’s opposition was filed on June 5, and Defendants’ reply on June 12.

In their motion to dismiss, Defendants argued that Immunex’s complaint was deficient because it did not sufficiently plead “how” Dupixent® “competes” with a reference antibody, as recited in the ’487 patent claims. Defendants invite Immunex to amend its complaint, to remedy this. In their opposition, Immunex maintained that the allegations in its complaint were more than sufficient, and that Defendants sought to impose pleading requirements that went beyond those set forth by the Supreme Court in Iqbal and Twombly.

On June 21, 2017 the Court denied Defendant’s motion to dismiss. It found Immunex pleaded sufficient facts to raise a right to relief above the speculative level by alleging “facts that plausibly demonstrate how Defendant’s drug Dupixent and its active ingredient dupilumab practice each element of at least one patent claim.”

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